Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05847855
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-04-27
Brief Title:
Multi-dimensional Fragmentomic Assay for Early Detection of Pancreatic Neuroendocrine Tumors
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Multi-dimensional Fragmentomic Assay for Early Detection of Pancreatic Neuroendocrine Tumors a Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective study aims to evaluate the sensitivity and specificity of an integrated model using fragmentomic profiles of plasma cell-free DNA for early detection of pancreatic neuroendocrine tumors
Detailed Description:
Pancreatic neuroendocrine tumors pNETs are insidious and difficult to diagnose early Approximately 368 of pNET patients have lymph node metastasis1 and 20 -64 of patients have liver metastasis at the time of diagnosis2 The prognosis of pNETs is closely related to tumor grade and the American Joint Committee on Cancer AJCC staging Among patients with known pathological grades in the United States well-differentiated NETs had the highest median overall survival OS 162 years moderately differentiated NETs had the worse OS 83 years and poorly differentiated or undifferentiated NETs had the worst OS 10 months3 The 5-year overall survival rates of localized locally advanced and metastatic pNETs were 93 77 and 27 respectively4 Given that the prognosis of early-stage pNETs is significantly better than that of advanced pNETs early detection of pNETs can provide a cure opportunity and significantly improve survival
In the past few decades the application of 68Ga-DOTANOC PETCT magnetic resonance imaging MRI computed tomography CT and endoscopic ultrasound EUS has improved the detection rate of pNETs But their application is limited by high costs lack of sufficient sensitivity or specificity and radiation exposure Therefore there is an urgent need for accurate and less invasive approaches to use in clinical practice for the early detection of pNETs
Recently the study of cell-free DNA cfDNA has provided a noninvasive approach for the diagnosis of solid malignancies cfDNAs represent extracellular DNA fragments released from cell apoptosis and necrosis into human body fluids like plasma thus carrying the genetic and epigenetic information from the cell and tissue of origin5 Among them circulating tumor DNA ctDNA as a part of the total cfDNA is released into the blood by tumor cells6 cfDNA fragmentomics depends on whole genome sequencing and its characteristics mainly include copy number variation CNV nucleosome footprint fragment length and motif5 7 8 with targets covering the entire genome level cfDNA fragmentomics has shown excellent predictive performance in multiple studies5 9-11 Therefore this prospective study aims to evaluate the sensitivity and specificity of an integrated model using fragmentomic profiles of plasma cell-free DNA cfDNA for early detection of pancreatic neuroendocrine tumors
In the past few decades the application of 68Ga-DOTANOC PETCT magnetic resonance imaging MRI computed tomography CT and endoscopic ultrasound EUS has improved the detection rate of pNETs But their application is limited by high costs lack of sufficient sensitivity or specificity and radiation exposure Therefore there is an urgent need for accurate and less invasive approaches to use in clinical practice for the early detection of pNETs
Recently the study of cell-free DNA cfDNA has provided a noninvasive approach for the diagnosis of solid malignancies cfDNAs represent extracellular DNA fragments released from cell apoptosis and necrosis into human body fluids like plasma thus carrying the genetic and epigenetic information from the cell and tissue of origin5 Among them circulating tumor DNA ctDNA as a part of the total cfDNA is released into the blood by tumor cells6 cfDNA fragmentomics depends on whole genome sequencing and its characteristics mainly include copy number variation CNV nucleosome footprint fragment length and motif5 7 8 with targets covering the entire genome level cfDNA fragmentomics has shown excellent predictive performance in multiple studies5 9-11 Therefore this prospective study aims to evaluate the sensitivity and specificity of an integrated model using fragmentomic profiles of plasma cell-free DNA cfDNA for early detection of pancreatic neuroendocrine tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None